Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma

Stopped early · Phase 1/Phase 2

Conditions studied: Melanoma

In brief

The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.

Key facts

Study ID

NCT00671554

Run by

Prisma Health-Upstate

People needed

3

Starts

2008-04-01

Expected to finish

2009-03-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to give informed consent
• Male or female patient whose age is > 18 years of age
• Histological documented Stage IV malignant melanoma (American Joint Committee on Cancer (AJCC) sixth edition)
• Pathology report from tumor specimen verifying melanoma diagnosis
• Free of infection
• Hemoglobin> 9.0 grams per deciliter (gm/dL), White Blood Cells (WBC) >3000/ cubic millimeters (mm3), platelets> 100,000mm3
• Liver function test that are less than 2 times the upper limit of normal of the reference range for the testing laboratory
• Adequate cardiac function-any evidence of ischemic heart disease demonstrated by history, physical, or EKG will require referral to a cardiologist for evaluation and clearance prior to protocol therapy
• No immunotherapy within the past 3 months
• A minimum of 4 doses of lot-released, autologus Melaxin (1.0 million dendritomas)

You may not qualify if…

• Other malignancies in the past 5 years with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix
• Has received any immunosuppressive agent within 30 days prior to treat
• Creatinine> 2.5 milligrams per deciliter (mg/dL) or currently on dialysis
• Positive serum pregnancy test, breast-feeding,or planning to conceive or father or father a child in the period surrounding the study as described in the informed consent.
• Women of childbearing potential who cannot follow the directions for birth control
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
• Positive Rdonr panel (Human Immunodeficiency virus (HIV) 1, 2; Human T-lymphotropic virus (HTLV-1,2); Hepatitis B and C)
• History of a seizure disorder
• Brain metastases that have progressed within the last 6 months
• No measurable disease

Where it is running

• Cancer Center of Carolinas/Clinical Research Unit 3rd Floor — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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